# K062126: Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135

- Pathway: 510(k) (Special)
- Applicant: Biosphere Medical, Inc.
- Decided: Aug 9, 2006 after 14 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003105 (2001). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003105: Biosphere Medical Infusion Catheter, Biosphere Medical (2001) Summary page 1.

## Most influential descendants
- K110459: Surefire Infusion Catheter System (2011), 9 descendants of its own
- K121677: Surefire HI-Flow Microcatheter (2012), 7 descendants of its own
- K143588: Surefire Infusion System 021 (2015), 6 descendants of its own
- K160662: Surefire Infusion System (2016), 5 descendants of its own
- K171355: Surefire Precision Infusion System (2017), 4 descendants of its own

## Indications for use
The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

Source page: https://510kreport.com/device/K062126
Methodology: https://510kreport.com/methodology